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Bipartisan Bill to Curb Investment in Chinas Biotech Sector

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U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechno...

Pazdur Recommends Restructuring FDA

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Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successfu...

Diamantas Tries to Win Back Rare Disease Advocates

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FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease...

Faulty Drug Supply Chain Hurts Seniors: Hearing

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The Senate Special Committee on Aging hears testimony on how an unsecure U.S. drug supply chain is harming older patients.

FDA Cites QOL Medical for Misleading Promotion of Sucraid

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FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) ...

FDA Warns Brazilian Drug Maker Over Records Request

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FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed ...

HealthPartners Neuroscience Center BIMO Issues

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FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations ...

3-Year New Clinical Investigation Exclusivity Guidance Explained

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Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

Senate Committee Postpones FDA Funding Bill Consideration

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Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republ...

FDA Accepts 1st Drug-Induced Liver Injury Tool

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FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug...